The FDA cited Richard Wolf Medical Instruments for CAPA and complaint procedures following a June 26 to July 17 inspection of the company’s Vernon Hills, Illinois facility.
Agency investigators found the company’s CAPA procedure did not properly identify corrective actions for non-conforming products and the facility did not adequately document corrective actions, root causes and effectiveness checks.
The facility also lacked a quality procedure or work instruction for third-party supplier corrective action requests and did not ensure that its devices were produced in accordance with federal law.
The agency also faulted the devicemaker for its complaint procedures, noting that its form for documenting complaint activities did not include a date and signature of the performer or a verifier for the investigation.
In addition, the facility failed to properly document changes to documents or equipment maintenance activities, according to the Form 483.
Read the Wolf Medical Instruments Form 483 here: www.fdanews.com/09-27-18-wolf.pdf. — Zack Budryk